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Associate Director Quality Control

Company: Albireo Pharma, Inc.
Location: Boston
Posted on: June 26, 2022

Job Description:

Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo's lead product, BylvayTM (odevixibat), was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company is progressing a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. For more information on Albireo, please visit Summary: The Associate Director of Quality Control is responsible for , operational leadership for both drug substance and drug product. Lead efforts to meet company objectives through manufacturing and development support, including product quality testing, method validation, method transfer, reference standards, and stability testing. The incumbent is responsible for ensuring all company, regional, and global standards and regulations are met, and that the department is developed and maintained to a standard that ensures the quality of products and materials produced by our contracted partners. Assist with all CMC Quality activities in preparation of the Phases 1-3 and Commercialization (Regulatory filing).This role reports to the Director of Quality Operations and is based in Boston, MA. Starting date is flexible.What makes this role special:Seek to have a profound impact on young children and their familiesWork on a portfolio of multiple potential therapiesGain a rare diversity of commercial experience Provide input into strategy, as well as manage execution of the Quality Control functionHelp shape the culture and future of an emerging biopharma with a big visionCollaborate with a small, collegial team of good peopleLearn from leadership with deep experience and a history of successBe part of an early biopharma company in an excellent financial positionEnjoy great work/life balance, including flex hours, ability to work remotely in a hybrid model , generous holiday schedule and business-casual work environment Responsibilities (may vary): This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.Key Duties and Responsibilities:Lead the Quality Control function, effectively inertacting and collaborating with cross functional teams and managing assigned staff effectively. Lead efforts to ensure manufacturing and testing organizations (CMOs and test labs) are operating in a manner that is consistent with regulations and internal policies from a Quality Control perspective.Review, evaluate and approve executed Batch and control records for API and drug product including test results, Certificates of Analysis as applicable for conformace to specifications and analytical requirements.Provide Quality Control oversight of all in-process, raw material, stability, reference standards and final product testing for clinical and commercial product manufacturing.Review and analysis of all non-complaince events during tesing and production. Assessment of any trends and CAPAs and CAPA effectiveness. Tracking of API, DP batch record status and linage.Management of Albireo's commercial product stability program including oversight of DS and DP stability programs, review and analysis of data, establish trends and generation of stability reports.Ensure contract service providers (i.e. CMOs, CTOs, etc) adhere to strict data integrity regulatory policies and provide constant oversight of CSP operations to confirm data is ALCOA (accurate, legible, Contemporaneous, original, Attributable) and traceable to the raw data source. Manage the reference standard program to ensure adequate quanities and timely supply of reference/working standards and markers including qualifications and re-qualifications at each CMO and test laboratories.Coordinate efforts for method validation and transfer of methods for commercial, clinical and development projects as applicable in coordination with Albireo CMC/Analytical and CMO/CTOAnalytical/QC. Support Analytical and CMOs to establish method suitability through proper testing and documentation.Review and approval all protocols and reports associated with stability, method validation and method transfer.Review and/or approval of test methods, relevant protocols and reports, specifications and Certificates of Analysis, assessment of temperature excursionsManage, coordinate internal changes and at CSPs using Albireo's Change Control procedures.Assure that source data and information is maintained and traceable. Maintain appropriate documentation to demonstrate the review and acceptance of the test data.Prepare Annual Product Review and Quality Management Review reports based on review of internal data or as provided from CSP for applicable productsContribute, QC check and help organize reviewed manufacturing information and data for inclusion in regulatory filings (CTD/NDA/BLA or IND, etc.)Assist with conducting and ensuring internal QC checks and reviews of the data generated by the Contract Sites Represent QC at internal and CSP project team meetings. Effectively communicate and support team needs. Qualifications:B.S. or M.S. in Chemistry or related science degree required (Additional experience may be substituted for the advance degree)Minimum (7)years of experience in QC and/or Analytical Quality within the Pharmaceutical Strong working knowledge of Analytical sciences with the understanding of industry and regulatory expectations and requirements for both clinical and commercial application with the ability to leverage to provide management and direction supporting the QC function and Albireo's objectives.Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations.Good understanding of product process and development, from discovery to commercializationKnowledgeable with phase-appropriate CGMP regulations and ICH or other industry guidance.Experience with the CMC and Regulatory Filing requirementsSmall molecule experiencePI181584917

Keywords: Albireo Pharma, Inc., Boston , Associate Director Quality Control, Executive , Boston, Massachusetts

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